Quality Risk Analyst

Job title:

Quality Risk Analyst

Company:

RoslinCT

Job description

Quality Risk AnalystLocation: Edinburgh BioQuarterWho are we?We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.Find out more about what we do !Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package – we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your New Role

• We are looking for a Quality Risk Analyst to join our growing Quality team here at RoslinCT.
• You will be responsible for coordinating quality risk management across departments in accordance with ICH guideline Q9.
• This position will support science-based decision-making and will develop and maintain an interactive risk register which highlights key risks and mitigation strategies for the leadership team.
• Define, deploy, and review the quality risk management process, ensuring resources are in place.
• Develop and maintain Risk Management policies, procedures, and methodologies.
• Lead and conduct detailed risk assessments, creating contingency plans to minimise crisis impact.
• Monitor and report on risk management performance metrics.
• Apply tools like FMEA, FMECA, FTA, and statistical analysis for risk assessment.
• Facilitate stakeholder meetings to discuss risk status and mitigation.
• Tracks industry trends to adapt risk strategies accordingly.
• Partner with internal and external stakeholders, including customers and regulatory bodies.

About you

• Experience in a Pharmaceutical Quality department in a commercial manufacturing environment, preferably Contract Manufacturing.
• Proven work experience as a Risk Analyst or similar position.
• A clear understanding of GMP, regulatory and quality management as applied to Advanced Therapy Medicinal Products.
• Competence in reporting and presenting internally/externally (MHRA visits, customer visits, training, auditing).
• Demonstrable ability to make decisions, analyse information in a logical manner and be able to prepare coherent investigative and/or technical reports.
• Excellent knowledge of risk analysis methodologies and tools.
• Experience in leading and engaging a team as well as strong influencing, motivational, and communication skills.
• Experience in data interpretation and analysis.
• Proficient in risk management software.

• Competent in computer packages including Microsoft Office and an electronic quality management package.

Qualifications:

• The successful candidate will be educated to degree level (or equivalent qualification) in Biology, Chemistry or Pharmacy.

Next StepsIf this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and what you could bring o the role at RoslinCT.At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at . We’re here to assist and make things as smooth as possible for you.RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

Expected salary

Location

Edinburgh

Job date

Sat, 07 Jun 2025 04:49:21 GMT

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